Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use

NCT03883386 on ClinicalTrials.gov Phase 2 University of Michigan (academic or other) Started 2019-06-24 Terminated

Riskier than 38% of active trials

Model scores of the 29,894 trials active now.

Model score 14% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (1,198 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2019-10-18, after 2019-06-24 start.

Reason given by the sponsor: “enrollment”

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2019-10-18. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: painbonepatientscsfchronic
Phrases that lowered it: releaseassess thecriteriamonthmean
Design: crossover (lowers risk) · Design
Sponsor's past termination rate: 10.2% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Drug's FAERS reports marked serious: 44.2% (lowers risk) · Drug's FDA history
Has a data monitoring committee: not given (lowers risk) · Design
Blinding: triple (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 151 (lowers risk) · Sponsor's track record
Maximum age: 99 (lowers risk) · Who can join
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 4.1% (lowers risk) · Drug's FDA history
Primary purpose: supportive care (lowers risk) · Design
Drug's FAERS reports in the prior 12 months: 8671 (lowers risk) · Drug's FDA history
Sponsor's past trials: 510 (raises risk) · Sponsor's track record
Drug's FAERS reports before start: 69198 (lowers risk) · Drug's FDA history
Minimum age: 12 (raises risk) · Who can join
Responsible party: principal investigator (lowers risk) · Design
Number of arms: 2 (raises risk) · Design

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 2
Number of arms: 2
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: supportive care (typical: treatment)
Blinding: triple (typical: none)
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 0
Keywords listed: 1

Who can join

Minimum age: 12 (typical: 18)
Maximum age: 99 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 510 (typical: 32)
Sponsor's past termination rate: 10.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 151 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 69198 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 8671 (typical: 412.5)
Drug's FAERS reports marked serious: 44.2% (typical: 85.6%)
Drug's FAERS reports with a death: 4.1% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: loratadine

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

Novel Preventive Approach Against Filgrastim-Induced Bone Pain in Cancer Patients NCT06265077 · started 2024 · scored riskier than 43% of active trials completed
Prevention of Pegfilgrastim-Induced Bone Pain (PIBP) NCT00602420 · started 2008 · scored riskier than 95% of active trials completed
Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis NCT03401060 · started 2018 · scored riskier than 67% of active trials completed
Dexamethasone for Pain Flare After Radiotherapy of Painful Bone metastasesZonMW 11510009 NCT01669499 · started 2012 · scored riskier than 91% of active trials completed
Prevention of Osteoporosis in Bone Marrow Transplantation (BMT) Patients NCT00824993 · started 2008 · scored riskier than 88% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.